bioequivalence study of divalproex sodium dr tablets 500 mg of dr. reddy's under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to assess the bioavailability of divalproex sodium dr tablets 500 mg versus depakote dr 500 mg tablets with a washout period of 10 days in healthy subjects.

an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of divalproex sodium dr 500 mg tablets of dr.reddy's laboratories limited, generics, india comparing with that of depakote® dr (containing divalproex sodium) 500 mg tablets of abbott laboratories pr ltd., barceloneta, pr, in healthy, adult, human subjects under fed conditions.

Eligibility criteria:
inclusion criteria: subjects must fulfill all of the following criteria to be considered for inclusion into this study: * subjects who will provide written informed consent. * subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive)weighing at least 50 kg. * having a body mass index (bmi) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2 * subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study. * subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance. * availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent. exclusion criteria: the subjects will be excluded based on the following criteria during screening and during the study * subjects incapable of understanding the informed consent. * subjects who have: * systolic blood pressure less than 90 mm of hg and more than 140 mm of hg * diastolic blood pressure less than 60 mm of hg and more than 94 mm of hg. minor deviations (2-4 mm of hg) at check-in may be acceptable at the discretion of the physician/investigator. * pulse rate below 50/min and above 100/min. * history of hypersensitivity or idiosyncratic reaction to divalproex sodium or any other related drugs. * any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. * consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study. * regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and during sampling period * subjects who have taken over the counter or prescribed medications and enzyme modifying or any systemic medication for during the last 7 and 30 days respectively before dosing. * subjects who have participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study. * subjects with clinically significant abnormalities (such as laboratory findings, ecg, x-ray,drugs of abuse, alcohol etc.,) and/or with significant diseases (such as hiv, hcv, syphilis,hepatitis b etc.,). * female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study.

Keywords: bioequivalence crossover divalproex sodium